Efficacy of 2 Probiotics During Nicotine Replacement Therapy on Withdrawal Symptoms Associated With Smoking Cessation

A Double-blind Randomized Placebo-controlled Trial Assessing the Effectiveness of Two Probiotic Products During Nicotine Replacement Therapy for Managing Withdrawal Symptoms Associated With Smoking Cessation

Quitting smoking is a big decision, a decision to achieve better health. Trying to quit smoking can be stressful. The prospect of dealing with withdrawal symptoms, fear or failure to change the routine, can also be sources of stress.

Withdrawal from nicotine is characterized by symptoms that include anxiety, irritability, hunger and cravings for more tobacco. Nicotine creates a dependency so that the body develops a need for a certain level of nicotine at all times. Unless that level is maintained symptoms of withdrawal appear.

For tobacco users trying to quit, symptoms of withdrawal from nicotine are unpleasant and stressful, but they are temporary.

Research has demonstrated the relative effectiveness of pharmacotherapy treatments in smoking cessation but no studies have examined the effects of the probiotics on the withdrawal symptoms associated with the tobacco cessation during nicotine replacement therapy (NRT).

The purpose of this study is to assess the effectiveness of two probiotic products during NRT for managing withdrawal symptoms associated with smoking cessation.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Dietary supplement: Probiotic L008-1; Dietary supplement: Probiotic L008-2; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1J2G2
      • Q & T Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults aged 18-65 years
• Moderate or heavy smokers as defined by:

a score at the Fargerström Test for Nicotine Dependence ≥ 5, and who smoke more than 10 cigarettes per day.

• Participants willing to stop smoking, corresponding to a score of 6 or 7 to the Motivation To Stop Scale. The MTSS is a one-item questionnaire with 7 possible choices, from 1 (lowest level of motivation to stop smoking) to level 7 (highest level of motivation to stop smoking).
• Participants need to be able to understand and consent to, and willing to comply with study procedures.
• Willingness to discontinue consumption of probiotic supplements and food containing added probiotics or and/or prebiotics (e.g. yoghourts, with live, active cultures or supplements).

Exclusion Criteria:

• Positive pregnancy test in women of child-bearing potential
• Pregnant or breast-feeding or planning on becoming pregnant.
• Women of child-bearing potential not using effective contraception, wich include :

Hormonal contraceptives including combined oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormonal implants; Intrauterine devices (IUD) or Intrauterine system (IUS); Tubal ligation; Vasectomy of partner; Double barrier method (use of physical barrier by both partners, e.g. male condom and diaphragm, male condom and cervical cap)

• Use of another investigational product within 3 months of the screening visit.
• Currently being treated for any known illnesses or conditions that may impact perceived health such as HIV/AIDS, immune modulating diseases (autoimmune, hepatitis, cancer, etc.), diabetes, kidney or liver disease, gastrointestinal diseases (e.g. gastric ulcers, Crohn's, ulcerative colitis, etc.)
• Suffered or suffering from heart attack, angina, heart arrhythmias, stroke, heart disease, thyroid problems, and diabetes requiring insulin.
• Participants with eczema, psoriasis, dermatitis or urticaria.
• Participants with soy or milk allergy.
• Participants with allergies to adhesive tape or bandages.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic L008-1; Encapsuled combinaison of 2 probiotics	Dietary supplement: Probiotic L008-1; Dosing regimen of 2 capsules daily, once per day, for 14 weeks
Experimental: Probiotic L008-2; Encapsuled combinaison of 2 probiotics	Dietary supplement: Probiotic L008-2; Dosing regimen of 2 capsules daily, once per day, for 14 weeks
Placebo Comparator: Placebo; Encapsuled non active ingredients	Other: Placebo; Dosing regimen of 2 capsules daily, once per day, for 14 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of the withdrawal symptoms assessed by the Mood and Physical Symptoms Scale (MPSS)	The MPSS(M) score, corresponding to the sum of the 7 items of the MPSS mood subscale, will be compared between groups, daily between week 2 and 4 (first 2 weeks of tobacco abstinence) and week 12 and 14 (first 2 weeks after the end of NRT), and weekly for the other weeks. For weekly comparisons, an average of daily scores will be done for the respective weeks. The score will also be compared in time within groups, using the baseline ratings as covariates	MPSS will be self-administered daily during 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of anxiety and depression assessed by the HADS questionnaire		measured 6 times up to 16 weeks
Evolution of nicotine addiction assessed by the Fargerström Test for Nicotine Dependence		measured 3 times up to 16 weeks
Difference in tobacco abstinence between arms, determined by levels of exhaled CO and salivary cotinine dosage		measured 6 times up to 16 weeks
Evolution of body weight		measured 6 times up to 16 weeks
Evolution of food cravings	Assessed by the Food Cravings Self-Questionnaire	self-reported, weekly, up to 16 weeks
Tolerance of the probiotics against placebo	Assessed by the reporting and the comparison of the Adverse events occurred in the different arms	up to 16 weeks
Effect of probiotics and smoking cessation on daily bowel movement frequency and consistency, assessed by the Bristol Stool Scale		Self-reported, daily during 16 weeks
Changes in the microbiome composition of participants in the probiotic groups compared to placebo	Assessed by the analyse of the stool samples collected	measured 2 times up to 16 weeks
Recovery of the probiotic strains in the stools	Assessed by the change in the probiotic strains concentration in the stools samples collected in all three arms.	measrured 2 times up to 16 weeks
Evolution of nicotine addiction assessed by a visual analog scale		measured 6 times up to 16 weeks
Comparison of MPSS(Craving or C), MPSS(Physical symptoms or P), and MPSS total scores (corresponding to the sum of MPSS(M), MPSS(C) and MPSS(M) scores)	daily comparison between week 2 and 4 (first 2 weeks of tobacco abstinence) and week 12 and 14 (first 2 weeks after the end of NRT), and weekly for the other weeks. The scores will be also compared in time within groups, using the baseline ratings as covariates. For weekly comparisons, an average of daily scores will be done for the respective weeks	MPSS will be self-administered daily during 16 weeks
Correlation between CO levels in exhaled air and salivary cotinine levels		measured 6 times up to 16 weeks

Collaborators and Investigators

• Sponsor: Lallemand Health Solutions
• Collaborators: MedQualis; Q & T Research
• Investigators: Principal Investigator: Luc Larrivée, MD, Q & T Research

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: June 17, 2015
• First Submitted That Met QC Criteria: July 2, 2015
• First Posted (Estimate): July 8, 2015

Study Record Updates

• Last Update Posted (Estimate): February 18, 2016
• Last Update Submitted That Met QC Criteria: February 16, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Substance Withdrawal Syndrome
• Other Study ID Numbers: smoking cessation